Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China

Ischemic Stroke Clinical Trial

Official title:

A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01612585
• Other study ID #: RSCMI-?
• Secondary ID: RSCMI-?
• Status: Active, not recruiting
• Phase: N/A
• First received: June 3, 2012
• Last updated: June 7, 2012
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2012
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational

Clinical Trial Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Description:

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.

Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals

Data will be collected in three aspects by three different forms as following:

Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients using Dengzhanxixin injection from 2012 to 2014

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Ischemic Stroke
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Guangdong Provincial Hospital of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction.	All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin.	The registry procedure will last 3 years only for patients using Dengzhanxixin	Yes